An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease (GEMINI LTS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00790933
First received: November 5, 2008
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

This multicenter, open-label study will collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.


Condition Intervention Phase
Ulcerative Colitis
Crohn's Disease
Drug: vedolizumab
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To determine adverse events, serious adverse events, results of standard laboratory tests and ECGs, time to major IBD-related events (hospitalizations, surgeries or procedures), and improvements in quality of life. [ Time Frame: A maximum of 7 years or until vedolizumab (MLN0002) becomes available in the U.S., whichever occurs first. ] [ Designated as safety issue: No ]

Estimated Enrollment: 2200
Study Start Date: May 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
A long-term safety study involving intervention followed by observation.
Drug: vedolizumab
Enrolled patients will receive vedolizumab (MLN0002) every 4 weeks, starting at Week 0, for up to a maximum of 7 years. The dosing period will be followed by a 16-week post-treatment observation and safety assessment period.Patients will also receive safety phone calls at 6-month intervals for 2 years following receipt of the last dose.
Other Name: MLN0002

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. a. Previous treatment in Study C13004, Study C13006, Study C13007, or Study 13011 that, in the opinion of the investigator, was well tolerated OR b. Moderate to severe Crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)
  2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol

Exclusion Criteria:

1. Development of any new, unstable, or uncontrolled disease

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790933

  Show 41 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00790933     History of Changes
Other Study ID Numbers: C13008
Study First Received: November 5, 2008
Last Updated: June 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014